# 510(k) Report

> Predicate family trees, recalls and adverse event reports for FDA medical device decisions (510(k), De Novo, PMA), built from FDA's public records and the summaries filed with them. 233,963 decisions; FDA decisions loaded through 2026-10-25, reloaded weekly.

## Pages
- [Device page](https://510kreport.com/device/K252726): one per submission number (K######, DEN######, P######). Predicates with the summary page they were read from, line of descent, descendants, recalls of the device and its family, review time against its product code. Plain-text twin: [/device/K252726.md](https://510kreport.com/device/K252726.md).
- [Product code page](https://510kreport.com/product-code/MHX): one per three-letter FDA product code. Decisions, 510(k) review times, recalls and MAUDE reports by year; most-cited predicates. Plain-text twin: [/product-code/MHX.md](https://510kreport.com/product-code/MHX.md); data by year: [/product-code/MHX.csv](https://510kreport.com/product-code/MHX.csv).
- [Company page](https://510kreport.com/company/zavation-medical-products): one per FDA applicant name. Decisions by year and pathway, the product codes it files in, its 510(k) review times against FDA's median for the same codes and years, whose devices its devices cite as predicates and which firms cite its devices, and recalls linked to its devices. Plain-text twin: [/company/zavation-medical-products.md](https://510kreport.com/company/zavation-medical-products.md).
- [Share image](https://510kreport.com/og/device/K252726.png): a PNG of any device's lineage figure.
- [Search](https://510kreport.com/search?q=insulin+pump): device names, companies and product codes.
- [Methodology](https://510kreport.com/methodology): sources and update schedule, how family trees are built, how predicates are read and checked, measured accuracy, coverage.
- [Device Review Tracker](https://510kreport.com/tracker): free monthly digest of decisions and Class I recalls, on the web and by email.

## Guides
Each answers one question with figures computed from all of FDA's records, recomputed weekly.
- [How long does a 510(k) take?](https://510kreport.com/guides/how-long-does-a-510k-take)
- [How to find a predicate device](https://510kreport.com/guides/how-to-find-a-predicate-device)
- [510(k) or De Novo: what if there is no predicate?](https://510kreport.com/guides/510k-or-de-novo)
- [The most-cited predicate devices](https://510kreport.com/guides/most-cited-predicate-devices)
- [Recalls in a device’s family tree](https://510kreport.com/guides/recalls-in-the-family-tree)
- [Who clears the most 510(k)s?](https://510kreport.com/guides/most-active-510k-applicants)

## Paid report
- [510(k) Report](https://510kreport.com/report): a report on one device concept, $995. It finds the product code and regulatory pathway, ranks candidate predicates side by side, and weighs their family trees' recall risk, the code's review times and its post-market record, with every figure linked to its FDA source. Ordered and paid online; built from the buyer's answers and emailed as a PDF, usually within a few hours.
- [Sample report (PDF)](https://510kreport.com/assets/sample/510k-report-sample.pdf): a full report on a handheld pain relief laser. Summary page: [/report/sample](https://510kreport.com/report/sample).